BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 20179412 · Received September 10, 2024

    Report

    Report Number
    2025587-2024-05047
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    August 19, 2024
    Report Date
    September 10, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000716141
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10:  PRODUCT ID L-EVOLUTFX-2329; PRODUCT LOT/SERIAL NUMBER UNKNOWN; PRODUCT TYPE: COMPRESSION LOADING SYSTEM (CLS) PRODUCT ID D-EVOLUTFX-2329; PRODUCT LOT/SERIAL NUMBER UNKNOWN; PRODUCT TYPE: DELIVERY CATHETER SYSTEM (DCS) PRODUCT ID EVFXPLUS-34 (SERIAL: (B)(6)); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: (B)(6) 2024. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE (J211900) WAS IMPLANTED AND INACTIVATED. A SECOND VALVE (J264678) WAS THEN IMPLANTED IN THE AORTIC POSITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337250 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVFXPLUS-29 00763000716141

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention SEE H11...